Byetta

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

exenatide

Saatavilla:

AstraZeneca AB

ATC-koodi:

A10BJ01

INN (Kansainvälinen yleisnimi):

exenatide

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

Byetta is indicated for treatment of type-2 diabetes mellitus in combination with:metformin;sulphonylureas;thiazolidinediones;metformin and a sulphonylurea;metformin and a thiazolidinedione;in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.

Tuoteyhteenveto:

Revision: 29

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-11-20

Pakkausseloste

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BYETTA 5 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
BYETTA 10 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
exenatide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
diabetes nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor, pharmacist, or
diabetes nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Byetta is and what it is used for
2.
What you need to know before you use Byetta
3.
How to use Byetta
4.
Possible side effects
5.
How to store Byetta
6.
Contents of the pack and other information
1.
WHAT BYETTA IS AND WHAT IT IS USED FOR
Byetta contains the active substance exenatide. It is an injectable
medicine used to improve blood
sugar control in adults with type 2 (non-insulin dependent) diabetes
mellitus.
Byetta is used with other diabetic medicines called metformin,
sulphonylureas, thiazolidinediones and
basal or long acting insulins. Your doctor is now prescribing Byetta
as an additional medicine to help
control your blood sugar. Continue to follow your food and exercise
plan.
You have diabetes because your body does not make enough insulin to
control the level of sugar in
your blood or if your body is not able to use the insulin properly.
The medicine in Byetta helps your
body to increase the production of insulin when your blood sugar is
high.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BYETTA
DO NOT USE BYETTA:
-
If you are allergic to exenatide or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist, or diabetes nurse before using Byetta

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Byetta 5 micrograms solution for injection in pre-filled pen
Byetta 10 micrograms solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres
(mcl), (0.25 mg exenatide
per mL).
Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres
(mcl), (0.25 mg exenatide
per mL).
Excipient with known effect:
Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Byetta 10 mcg: Each dose contains 88 mcg metacresol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Byetta is indicated for treatment of type 2 diabetes mellitus in
combination with:
- metformin
- sulphonylureas
- thiazolidinediones
- metformin and a sulphonylurea
- metformin and a thiazolidinedione
in adults who have not achieved adequate glycaemic control on
maximally tolerated doses of these
oral therapies.
Byetta is also indicated as adjunctive therapy to basal insulin with
or without metformin and/or
pioglitazone in adults who have not achieved adequate glycaemic
control with these medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Immediate-release exenatide (Byetta) therapy should be initiated at 5
mcg exenatide per dose
administered twice daily (BID) for at least one month in order to
improve tolerability. The dose of
exenatide can then be increased to 10 mcg BID to further improve
glycaemic control. Doses higher
than 10 mcg BID are not recommended.
Immediate-release exenatide is available as either a 5 mcg or a 10 mcg
exenatide per dose pre-filled
pen.
3
Immediate-release exenatide can be administered at any time within the
60-minute period before the
morning and evening meal (or two main meals of the day, approximately
6 hours or more apart).
Immediate-release exenatide should not be administered after a meal.
If an i